Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05514418 |
| Other study ID # |
SPH-2021-144 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 12, 2022 |
| Est. completion date |
April 12, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
Makerere University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Uganda uses a threshold of 1,000 copies/ml to determine HIV viral non-suppression among
people living with HIV/AIDS (PLHIV) on treatment, which is indicative of either poor
adherence or HIV virologic treatment failure; as per the recent WHO recommendations. The use
of this high threshold of 1,000 copies/ml has resulted into an increase in the number of
PLHIV having low-level viraemia (≥50 to <1,000 copies/ml) from 11.0% in 2017 to 35.0% in 2020
in Uganda. Different studies in developed countries have shown that low-level viraemia is
associated with HIV drug resistance, and despite this, there is no intervention to manage and
control low-level viraemia (LLV), as per the recent Uganda national HIV guidelines. With this
increasing and unmanaged low-level viraemia (LLV), Uganda might never achieve the global
targets of ending AIDS as epidemic by 2030, as stipulated by target 3.3 of SDG 3.
This study will therefore determine the effectiveness of intensive adherence counselling on
achieving a non-detectable viral load (below 50 copies/ml) in the management of LLV among
PLHIV on ART in Uganda. This study will generate useful information that might guide the
review of the national HIV guidelines, to control and manage LLV among PLHIV on ART; and
thereby enable Uganda to achieve the global goals of SDG 3, Target 3.3 and the national
targets of Vision 2040.
Description:
Study design This study will be a cluster randomized clinical trial, which will determine the
effectiveness of IAC in achieving a non-detectable viral load among PLHIV on ART with LLV
from selected health facilities from all the four regions of Uganda. The outcome of the study
will be the proportions of PLHIV with a non-detectable viral load in both the intervention
and control arms of the study.
Study setting The study will be conducted in selected health facilities from each of the four
regions in Uganda (Central, Eastern, Northern and Western).
Study population The study will comprise of PLHIV on ART who have had recent VL result with
LLV.
Sample size A sample size of 79 participants per arm will be estimated from; n = [(Zα/2 +
Zβ)2 × {(p1 (1-p1) + (p2 (1-p2))}]/(p1 - p2)2 (Sakpal, 2010; Sullivan, 2020); with a power of
90% and a 5% level of significance to detect a 15% difference in PLHIV on ART who get a
non-detectable viral load between those offered IAC and those who are not. IAC is an
intervention used to manage PLHIV with a non-suppressed VL and 70% of these PLHIV attain
viral suppression (WHO, 2016); and therefore, we assume that p2 is 0.7. PLHIV with LLV have
suppressed VL and we assume IAC to even be more effective at about 90% in creating a
non-detectable VL in these PLHIV, hence we assume p1 to be 0.9.
An equal sample size of 12 participants for each of the 8 clusters will be estimated from
(Hemming et al., 2011) where nI is the number of participants required for each arm, k is the
number of clusters, and p is the intra-cluster correlation estimate, which is 0.0180
(Barnhart et al., 2016), thus a total of 96 participants is required. Considering a design
effect of 1.126 and an attrition rate of 20%, the resultant total sample size of 136
participants per study arm will be used, hence a total 17 participants will be recruited per
cluster.
Sampling procedure The clusters will be grouped into pairs based on the geographical location
(Lorenz et al., 2018). In each cluster pair, one cluster will be randomly assigned to the
intervention arm, which will receive intensive adherence counselling (IAC) as an intervention
to manage LLV. Hence both the intervention and control arms will be balanced.
Data collection The study will take place at the HIV clinics of the selected health
facilities (clusters), and the selected research assistants who will either be ART
counsellors or clinicians or nurses will be oriented and trained about the study and also
re-mentored in how to offer IAC sessions.
PLHIV on ART with recent VL results having LLV who will have consented to take part in the
study will sequentially be recruited into the clusters, and the demographic data will be
collected.
Control Arm (Standard of Care): This arm will comprise of clusters which will receive the
routine standard of care. These participants in these clusters will receive the normal
patient education and encouragement to continue with their ART at the start of the study.
They will not be reviewed monthly or offered any counselling for the entire three months.
These participants will be given an appointment after three months for repeat VL testing.
Intervention Arm (IAC arm): The participants of clusters in this arm will receive three
monthly sessions of intensive adherence counselling and psychosocial support, using the 5 A's
principles for chronic care (which include; Assess, Advise, Agree, Assist and Arrange). Each
monthly IAC session will be offered by the research assistants for about one hour, and
adherence will also be assessed by pill counts. Colour-coded IAC forms will be developed and
used to differentiate the study from routine IAC services for the non-suppressed patients;
and the study will be conducted on different days, from those on which the routine clinic
occurs.
Following the three months of the study, all the study participants in all the clusters both
in the control and intervention arms will be reviewed at the health facility and a repeat VL
done for each of the participants, to determine whether they have achieved a non-detectable
VL or not.
Statistical Analysis EpiData version 3.02 will be used for data entry, and analysis will be
done using Stata version 14. Descriptive statistics will be used to describe the sample size.
The proportions of PLHIV attaining a non-detectable VL in the intervention arm will be
compared with those PLHIV attaining a non-detectable VL in the control arm. The effectiveness
of intensive adherence counselling will be estimated using Cox regression models, adjusted
for sociodemographic factors.
